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Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding

This study has been terminated.
(Sponsor withdrew funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01564732
First Posted: March 28, 2012
Last Update Posted: July 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Dana Portenier, MD, Duke University Medical Center
  Purpose
The purpose of this study is to compare plicated laparoscopic adjustable gastric banding (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospective randomized clinical trial. We hypothesize the plicated procedure will provide greater short- and long-term excess weight loss than the standard procedure. There exists little prospective randomized data regarding this topic and the recent position statement from the American Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study. Further information on background and design of this study are provided in the detailed description.

Condition Intervention
Morbid Obesity Device: Standard-LAGB Device: Plicated-LAGB

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Multicenter Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Further study details as provided by Dana Portenier, MD, Duke University Medical Center:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 36 months ]
  • Quantitative Change in Hypertension [ Time Frame: 36 months ]
    Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.

  • Quantitative Change in Diabetes [ Time Frame: 36 months ]
    Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.

  • Quantitative Change in Hyperlipidemia [ Time Frame: 36 months ]
    Lipid levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.

  • Quantitative Change in Hypertriglyceridemia [ Time Frame: 36 months ]
    Triglyceride levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.


Enrollment: 17
Study Start Date: September 2013
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard-LAGB
Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
Device: Standard-LAGB
The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.
Other Name: Standard Laparoscopic Adjustable Gastric Banding Surgery
Experimental: Plicated-LAGB
Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
Device: Plicated-LAGB
At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.
Other Name: Plicated Laparoscopic Adjustable Gastric Banding Surgery

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Subjects must meet the following criteria to be eligible for study entry:

  1. Age between 18-60 years,
  2. Morbidly obese:

a. BMI > 40, or b. BMI > 35 + co-morbid obesity related disease condition c)BMI < or equal to 55

Exclusion Criteria: Subjects meeting the following criteria will be excluded from study entry:

  1. Patients with any major medical problems contraindicating surgery (eg.myocardial infarct within last 6 months, cancer within last 5 years, end stage renal/liver disease, etc.)
  2. Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
  3. Patients who elect to undergo a surgery other than a PLAGB or SLAGB
  4. Patient who is unwilling to be randomized to PLAGB or SLAGB
  5. Pregnant or planning pregnancy within 12 months
  6. Alcohol or drug addiction
  7. Established infection anywhere in the body at the time of surgery
  8. Previous history of bariatric surgery, gastric surgery, intestinal obstruction, or adhesive peritonitis.
  9. Family or patient history of autoimmune disease
  10. Hiatal Hernia > 3cm (as reported per radiology on pre-operative swallow study)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564732


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Dana Portenier, MD
Allergan
Investigators
Principal Investigator: Dana D Portenier, MD Duke University
Principal Investigator: Carol McCloskey, MD University of Pittsburgh
  More Information

Publications:

Responsible Party: Dana Portenier, MD, Assistant Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01564732     History of Changes
Other Study ID Numbers: Pro00033638
First Submitted: March 7, 2012
First Posted: March 28, 2012
Results First Submitted: April 25, 2016
Results First Posted: June 1, 2016
Last Update Posted: July 1, 2016
Last Verified: June 2016

Keywords provided by Dana Portenier, MD, Duke University Medical Center:
morbid obesity
gastric band

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms